Induction and Maintenance of Remission With Pentasa as Ulcerative Colitis Treatment

Ulcerative Colitis Clinical Trial

— IMPACT  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02261636
• Other study ID #: 000157
• Status: Completed
• Start date: January 2015
• Est. completion date: January 14, 2019

Study information

• Verified date: February 2019
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

For both induction of remission and in maintenance of remission, different doses and treatment durations are used in practice. The aim of this study is to assess how mesalazine is used in clinical practice, at which doses and for how long and how these differences impact the patient disease state and work productivity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 14, 2019
• Est. primary completion date: January 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients with mild to moderate active ulcerative colitis with disease extension beyond the rectum (= 10 cm) who will receive oral Pentasa treatment (Compact sachets and/or tablets) for the treatment of the current active episode or in whom on oral Pentasa maintenance treatment induction of remission treatment will be initiated by dose escalation. Treatment combined with Pentasa enema (1g/100ml) is allowed.

• Informed consent

Exclusion Criteria:

• Patients receiving treatment with one or more of the following: locally acting steroids (e.g. budesonide, beclomethasone), systemic steroids, immunosuppressants (e.g. thiopurines), biologicals (e.g. anti-Tumor Necrosis Factor-alpha)

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• mesalazine

Locations

Country	Name	City	State
Netherlands	Gelre Ziekenhuizen (there may be other sites in this country)	Zutphen

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

West R, Russel M, Bodelier A, Kuijvenhoven J, Bruin K, Jansen J, Van der Meulen A, Keulen E, Wolters L, Ouwendijk R, Bezemer G, Koussoulas V, Tang T, Van Dobbenburgh A, Van Nistelrooy M, Minderhoud I, Vandebosch S, Lubbinge H. Lower Risk of Recurrence wit — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to dose reduction		From Day 1 up to one year